Conversion Prograf® to Advagraf® at D7 Versus D90 After Liver Transplantation

NCT02105155 | Completed Phase 4 DMC

• 2 other identifiers: P 120907HAO 2012
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The best period for the conversion from Prograf (tacrolimus administered twice daily) to Advagraf (once-daily prolonged-release tacrolimus) remains unknown. The aim of this prospective, randomized, multicenter trial is to prove the non-inferiority of the early conversion (at D7) versus the conversion at D90 after liver transplantation. The primary objective will be to evaluate the incidence of a first biopsy-proven acute rejection in the 6 first months, and prove the non-inferiority of the conversion at D7 + / - 3 versus the conversion at D90 + / - 5 (reference group). If non-inferiority is proved, the two strategies will be compared in terms of superiority. 250 patients will be included. Three ancillary studies will be added : a PK study in a subgroup of 40 patients (20 patients per arm), an assay of the calcineurin activity on a subgroup of 40 patients, and a medicoeconomic study in all patients

Conditions

Immunosuppression After Liver Transplantation

Keywords

Liver transplantation,; Conversion (Prograf® to Advagraf®),; Prograf® ,; Advagraf® ,; acute rejection,; GFR

Outcome Measures

Primary Outcomes (1)

• First episode of acute rejection during the first 6 months

  First episode of acute rejection during the first 6 months

  6 months

Secondary Outcomes (3)

• Renal function

  6 months

• Adverse effects

  6 months

• Severity of acute rejection

  6 months

Study Arms (2)

Conversion at day 7 ± 3

EXPERIMENTAL

Conversion from Prograf to Advagraf at D7 ± 3

Drug: Conversion at day 7 ± 3 Prograf® to Advagraf®

Conversion at day 90±5

ACTIVE COMPARATOR

Conversion from Prograf to Advagraf at 90±5

Drug: Conversion at day 90±5 Prograf® to Advagraf®

Interventions

Conversion at day 7 ± 3 Prograf® to Advagraf® DRUG

Conversion from Prograf® (tacrolimus administered twice daily) to Advagraf® (once-daily prolonged-release tacrolimus) at day 7±3

Conversion at day 7 ± 3

Conversion at day 90±5 Prograf® to Advagraf® DRUG

Conversion from Prograf® (tacrolimus administered twice daily) to Advagraf® (once-daily prolonged-release tacrolimus) at day 90±5

Conversion at day 90±5

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years
• First liver transplantation
• No contra-indication to tacrolimus, mycophenolate mofetil or steroids
• Informed consent signed
• French Health Assurance

You may not qualify if:

• Combined transplantation
• Severe uncontrolled infection
• Hypersensitivity to tacrolimus or its excipients, to other macrolides, to mycophenolate mofetil or its excipients
• Pregnant or lactating woman, or women of childbearing potential without adequate method of contraception
• Cancer or pasthistory of cancer other than basal or squamous cell carcinoma or hepatocellular carcinoma suitable for liver transplantation
• Patients with renal impairment where GFR is less than 30ml/min
• HIV positivity

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Pitié Salpêtrière unité médicale de transplantion hépatique

Paris, 75013, France

Location

Related Publications (1)

• Allard M, Puszkiel A, Conti F, Chevillard L, Kamar N, Noe G, White-Koning M, Thomas-Schoemann A, Simon T, Vidal M, Calmus Y, Blanchet B. Pharmacokinetics and Pharmacodynamics of Once-daily Prolonged-release Tacrolimus in Liver Transplant Recipients. Clin Ther. 2019 May;41(5):882-896.e3. doi: 10.1016/j.clinthera.2019.03.006. Epub 2019 Apr 17.

  PMID: 31003735 DERIVED

Study Officials

• Yvon Calmus, MD, PhD

  Assistance Publique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 7, 2014
• Study Start: November 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 17, 2016
• Last Updated: December 8, 2017

Record last verified: 2017-11

Locations

FR (1)